1BRACAnalysis CDx™ is an in vitro diagnostic device intended for the qualitative detection
and classification of variants in the protein coding regions and intron/exon boundaries of the BRCA1 and BRCA2 genes
using genomic DNA obtained from whole blood specimens collected in EDTA. Single nucleotide variants and small insertions
and deletions (indels) are identified by polymerase chain reaction (PCR) and Sanger sequencing. Large deletions and duplications
in BRCA1 and BRCA2 are detected using multiplex PCR. Results of the test are used as an aid in identifying ovarian cancer
patients with deleterious or suspected deleterious germline BRCA variants eligible for treatment with Lynparza™ (olaparib).
This assay is for professional use only and is to be performed only at Myriad Genetic Laboratories, a single laboratory
site located at 320 Wakara Way, Salt Lake City, UT 84108.

The ScienceRecent Publications

Inhibition of Poly(ADP-Ribose) Polymerase in Tumors from BRCA Mutation Carriers

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Melanoma

Melanoma

About Myriad myPath™ Melanoma

Myriad myPath™ Melanoma is a unique molecular test created specifically for difficult-to-diagnose melanoma cases. By analyzing 23 genes, the test provides valuable additive molecular information unavailable from any other method for a more informed diagnosis.

Prostate Cancer

About Prolaris®

Prolaris® measures the expression level of genes involved with tumor proliferation, providing physicians with unique additional information about a patient’s prostate cancer prognosis and may be used with other clinical factors - providing valuable insight into treatment planning.

Letters of Medical Necessity

A healthcare provider may include a Letter of Medical Necessity (LMN) with a pre-authorization request, claim submission, or appeal to facilitate the insurance review process for the benefit of the patient. Our experience with insurance companies is such that we encourage healthcare providers to cover as many of the following points as possible that are applicable to the patient:

Explanation that the requested genetic test has been ordered by a physician

Explanation of the medical necessity for the test requested

If family history is cited, give as much family history as possible, including
specifics about relationship to patient, cancer site, age of cancer diagnosis
(alternatively, a detailed three-generation pedigree that contains this
information could be attached and referred to in the body of the letter)

Patient's diagnosis and prognosis, including age of onset and specific location
of cancer

Explanation that the genetic test is recognized as appropriate for inclusion in
this patient's treatment regimen

Treatment plan, including specific statements about anticipated impact of the
genetic test on the medical management of patient.

We remind you to read through the entire letter to make sure it makes sense for each patient.